Retrospective studies indicate that active surveillance for clinically localized, small renal masses (cT1a, \<=4cm) is safe. It is our hypothesis that active surveillance is safe and efficacious when compared prospectively to patients undergoing immediate intervention for their small renal mass.
Must have a solid, enhancing renal mass ≤4cm at its greatest dimension found on incidental scanning in the last 6 months.
Age ≥ 18 and able to read, understand and sign informed consent.
Must be willing to adhere to the treatment algorithm and time constraints therein.
Cannot have suspicion of metastases to the kidney if any other malignancy diagnosed within two years of study entry.
All adult patients (18-100) presenting with a clinically localized, solid renal mass (cT1a, \<=4cm).
Other
Prospective
Not listed
Disease-specific survival
Safety and Efficacy of active surveillance and delayed intervention for the SRM, measured by disease-free survival at 5-years.
Objective Safety and Tolerability of Percutaneous Renal Biopsy
Measured by observed total (minor and major) complications compared to historical complication rates for this procedure.
Quality-of-life outcomes for patients undergoing AS versus definitive therapy.
Measured by SF12 Questionnaire at enrollment, 6 and 12 months and annually thereafter.
To determine objective selection criteria for active surveillance.
Demographic (i.e. age, sex, race), clinical (i.e. comorbidities, medications, family history) and imaging characteristics (i.e. tumor size, enhancement patterns, tumor complexity) will be used to determine patients most suitable for active surveillance.
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Abramson Cancer Center at Penn Medicine
Lead sponsor
National Comprehensive Cancer Network
Collaborator
